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首页> 外文期刊>Trials >Study of negative?pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): protocol for a randomised controlled trial
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Study of negative?pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): protocol for a randomised controlled trial

机译：对阴性伤害治疗作为儿童急性燃烧的辅助治疗（C）：随机对照试验的议定书

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Although negative?pressure wound therapy (NPWT) is widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has not yet been adequately investigated, with research in the paediatric population particularly lacking. There is limited evidence, however, that NPWT might benefit children with burns, amongst whom scar formation, wound progression and pain continue to present major management challenges. The purpose of this trial is to determine whether NPWT in conjunction with standard therapy accelerates healing, reduces wound progression and decreases pain more effectively than standard treatment alone. A total of 104 children will be recruited for this trial. To be eligible, candidates must be under 17?years of age and present to the participating children's hospital within 7 days of their injury with a thermal burn covering 5% of their total body surface area. Facial and trivial burns will be excluded. Following a randomised controlled parallel design, participants will be allocated to either an active control or intervention group. The former will receive standard therapy consisting of Acticoat? and Mepitel?. The intervention arm will be treated with silver-impregnated dressings in addition to NPWT via the RENASYS TOUCH? vacuum pump. Participants' dressings will be changed every 3 to 5 days until their wounds are fully re-epithelialised. Time to re-epithelialisation will be studied as the primary outcome. Secondary outcomes will include pain, pruritus, wound progression, health-care-resource use (and costs), ease of management, treatment satisfaction and adverse events. Wound fluid collected during NPWT will also be analysed to generate a proteomic profile of the burn microenvironment. The study will be the first randomised controlled trial to explore the clinical?effects of NPWT on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management. Australian New Zealand Clinical Trials Registry, ACTRN12618000256279 . Registered on 16 February 2018.
机译：虽然负呢？压力伤口治疗（NPWT）广泛用于多种伤口类型的管理中，但尚未充分调查其作为急性燃烧的主要疗法的疗效，特别是在儿科人口中的研究特别缺乏。然而，有限的证据，即NPWT可能会使烧伤的儿童受益，其中疤痕形成，伤口进展和痛苦继续呈现主要的管理挑战。该试验的目的是确定NPWT是否与标准治疗加速愈合加速，减少伤口进展，并比单独的标准治疗更有效地降低疼痛。共有104名儿童将招募此审判。要符合条件，候选人必须低于17岁以下的年龄，并在伤害的7天内向参与儿童医院呈现，热灼热覆盖总体表面积的5％。将被排除面部和微不足道的烧伤。在随机控制的并行设计之后，参与者将被分配给主动控制或干预组。前者会收到由accicoat组成的标准治疗？和梅特尔？除了通过肾上腺素触摸之外，干预臂将用银浸渍的敷料处理吗？真空泵。参与者的敷料将每3到5天更换一次，直到伤口完全重新上翘。将研究重新上皮的时间作为主要结果。二次结果将包括疼痛，瘙痒，伤口进展，保健资源使用（和成本），易于管理，治疗满意度和不良事件。还将分析在NPWT期间收集的伤口流体，以产生烧伤微环境的蛋白质组学曲线。该研究将是第一个随机对照试验，用于探索临床症的临床？NPWT对儿科烧伤的影响，目的是确定治疗权证是否作为标准烧伤管理的兼容。澳大利亚新西兰临床试验登记处，ACTRN12618000256279 2018年2月16日注册。

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